Effects of Inhibiting Early Inflammation in Kidney Transplant Patients
NCT ID: NCT02495077
Last Updated: 2022-08-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
290 participants
INTERVENTIONAL
2015-11-02
2021-07-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to evaluate whether taking infliximab, which blocks tumor necrosis factor alpha (TNF-alpha), just prior to transplant surgery, along with usual transplant medicines will protect the donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy for a longer period of time.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treg Therapy in Subclinical Inflammation in Kidney Transplantation
NCT02711826
Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
NCT04294459
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
NCT02130817
Sequential Targeting of Cluster of Differentiation 52 (CD52) and Tumor Necrosis Factor (TNF) Allows Early Minimization Therapy in Kidney Transplantation
NCT02711202
Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants
NCT05525507
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental
rATG is co-administered with anti-TNFa (infliximab/Remicade®) plus maintenance therapy with tacrolimus, a mycophenolic acid derivative (either MMF or enteric coated MPA) and prednisone.
Infliximab
A single dose, of 3mg/kg infusion
Methylprednisolone
500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion
Mycophenolate Mofetil
Administered at a target dose of 2000mg daily, as tolerated, until study closure
Tacrolimus
Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure
Thymoglobulin®
Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated
Acetaminophen
30 to 60 minutes prior to the start of the infusion
* Tylenol, 600 to 1000mg by mouth or
* Suppository form
Loratadine
30 to 60 minutes prior to the start of the infusion
* Claritin (Loratadine) 10mg by mouth or
* Benadryl (Diphenhydramine) 25 or 50 mg by mouth
Prednisone
Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.
Diphenhydramine
30 to 60 minutes prior to the start of the infusion
* Claritin (Loratadine) 10mg by mouth or
* Benadryl (Diphenhydramine) 25 or 50 mg by mouth
Control
Rabbit anti-thymocyte globulin (rATG/Thymoglobulin®) plus placebo (Sterile normal saline) induction followed by maintenance therapy with tacrolimus, a mycophenolic acid derivative (either MMF or enteric coated MPA) and prednisone.
Methylprednisolone
500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion
Mycophenolate Mofetil
Administered at a target dose of 2000mg daily, as tolerated, until study closure
Tacrolimus
Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure
Thymoglobulin®
Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated
Acetaminophen
30 to 60 minutes prior to the start of the infusion
* Tylenol, 600 to 1000mg by mouth or
* Suppository form
Loratadine
30 to 60 minutes prior to the start of the infusion
* Claritin (Loratadine) 10mg by mouth or
* Benadryl (Diphenhydramine) 25 or 50 mg by mouth
Placebo for Infliximab
A single dose is volume matched to Infliximab (250mL) infusion
Prednisone
Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.
Diphenhydramine
30 to 60 minutes prior to the start of the infusion
* Claritin (Loratadine) 10mg by mouth or
* Benadryl (Diphenhydramine) 25 or 50 mg by mouth
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infliximab
A single dose, of 3mg/kg infusion
Methylprednisolone
500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion
Mycophenolate Mofetil
Administered at a target dose of 2000mg daily, as tolerated, until study closure
Tacrolimus
Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure
Thymoglobulin®
Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated
Acetaminophen
30 to 60 minutes prior to the start of the infusion
* Tylenol, 600 to 1000mg by mouth or
* Suppository form
Loratadine
30 to 60 minutes prior to the start of the infusion
* Claritin (Loratadine) 10mg by mouth or
* Benadryl (Diphenhydramine) 25 or 50 mg by mouth
Placebo for Infliximab
A single dose is volume matched to Infliximab (250mL) infusion
Prednisone
Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.
Diphenhydramine
30 to 60 minutes prior to the start of the infusion
* Claritin (Loratadine) 10mg by mouth or
* Benadryl (Diphenhydramine) 25 or 50 mg by mouth
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject must be able to understand and provide consent
3. Recipients of deceased donor kidney transplants (including re-transplants)
4. Negative crossmatch, actual or virtual, or a PRA of 0% on historic and current sera as determined by each participating study center
5. Donor kidneys from deceased donors and donors after cardiac death (DCD) with Kidney Donor Profile Indices (KDPI) ranging from ≥20 to \<95
6. Female participants of childbearing potential must have a negative pregnancy test upon study entry
7. Subjects must have a negative test result for latent tuberculosis (TB) infection (PPD, QuantiFERON, ELISPOT):
* Subjects who have a negative test result for latent TB infection within 1 year of transplant date are eligible for enrollment and no further action is required
* Subjects who have a negative test for latent TB infection that is greater than 1 year old are eligible for enrollment but are required to have a repeat test prior to transplantation.
Exclusion Criteria
2. Recipients of living donor transplants
3. Presence of other transplanted solid organ (heart, lung, liver, pancreas, small intestines) or co-transplanted organ
4. Human immunodeficiency virus positive (HIV+) recipients
5. Epstein-Barr virus Immunoglobulin G (EBV IgG) negative recipients
6. Hepatitis B surface antigen positive kidney transplant recipients
7. Hepatitis B core antibody positive kidney transplant recipients
8. Hepatitis B negative kidney transplant recipients that receive transplants from Hepatitis B core antibody positive donor
9. Hepatitis C Virus positive (HCV+) patients who are either untreated or have failed to demonstrate sustained viral remission for more than 12 months after anti-viral treatment
10. Recipients with a previous history of active TB
11. Recipients with a positive test for latent TB infection (PPD, QuantiFERON, ELISPOT), regardless of previous therapy
12. Any severe infection at the time of transplantation.
--Note: Severe infection determination will be made by the local site investigator.
13. Severe congestive heart failure (NYHA functional class III or higher)
14. Subjects with a known hypersensitivity to any murine/ mouse proteins
15. Subjects with any history of receiving any anti-tumor necrosis factor (anti- TNF) products
16. Subjects in whom rabbit anti-thymocyte globulin (Thymoglobulin®) or infliximab might not be tolerated
17. Subjects with a white blood cell count less than 3000/mm\^3
18. Subjects with a platelet count less than 100,000/mm\^3
19. Subjects with systolic blood pressure \<100 mm/Hg
20. Subjects with symptomatic orthostatic hypotension or currently requiring Midodrine for blood pressure support
21. Subjects from, or who have traveled, to endemic areas with a history of active histoplasmosis or, with a chest x-ray consistent with previous active histoplasmosis (no serological testing required) :
--Endemic regions determined by site based on local standard of care.
22. Subjects currently or formerly residing in regions of the United States that are highly endemic for coccidioidomycosis, and who have a positive serologic test for coccidioidomycosis:
--Endemic regions determined by site based on local standard of care.
23. Recipients are excluded if the local site decides to treat the recipient with fluconazole because of diagnosis or suspicion of fungal infection the donor
24. Subjects that receive IVIG treatment within 3 months of transplant or planned intravenous immunoglobulin (IVIG) treatment peri-transplant
25. Use of an investigational agent within 4-weeks prior to study entry.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinical Trials in Organ Transplantation
NETWORK
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter S. Heeger, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai, Recanati Miller Transplant Institute
Donald E Hricik, MD
Role: STUDY_CHAIR
University Hospitals of Cleveland, Division of Nephrology & Hypertension
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Mount Sinai Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
University of Wisconsin
Madison, Wisconsin, United States
University of Manitoba
Winnipeg, Manitoba, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
Hricik DE, Armstrong B, Alhamad T, Brennan DC, Bromberg JS, Bunnapradist S, Chandran S, Fairchild RL, Foley DP, Formica R, Gibson IW, Kesler K, Kim SJ, Mannon RB, Menon MC, Newell KA, Nickerson P, Odim J, Poggio ED, Sung R, Shapiro R, Tinckam K, Vincenti F, Heeger PS. Infliximab Induction Lacks Efficacy and Increases BK Virus Infection in Deceased Donor Kidney Transplant Recipients: Results of the CTOT-19 Trial. J Am Soc Nephrol. 2023 Jan 1;34(1):145-159. doi: 10.1681/ASN.2022040454. Epub 2022 Oct 4.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Division of Allergy, Immunology, and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation (CTOT)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIAID CRMS ID#: 20678
Identifier Type: OTHER
Identifier Source: secondary_id
DAIT CTOT-19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.